Safety and Immunogenicity Study of GX-70 in TB Patient

• Status: Withdrawn
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in patients with pulmonary tuberculosis of an investigational DNA vaccine being developed for the prevention of relapse of tuberculosis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

Criteria

Inclusion Criteria:

1. Subjects who voluntarily consented, after listening enough explanation for this study and investigational product.

2. Adults between 19 and 65 years.

3. TB patients without a history of TB diagnosis, who show positive on both AFB smear and TB-PCR

4. TB patients who satisfy following conditions: cavity spotted from chest imaging before TB therapy, positive on AFB smear 2 months after TB therapy.

Exclusion Criteria:

1. At 2 months after therapy started, AFB smear shows 1+ or higher, but TB PCR shows NTM positive.

2. If positive on AFB smear is resulted from dead MTB

3. Serious TB such as tuberculous encephalomeningitis

4. Patients with serious pulmonary symptom except TB

5. Patients show poor vital sign considered to be difficult to participate

6. Patients with heart, renal, or liver failure

7. Patients with infection, ulcer, edema, tattoo, scar, wound and other conditions in skin around 3cm of deltoid muscle that result inappropriate to inject through electroporation.

8. When thickness of skin around deltoid muscle which is to be injected exceeds 40mm

9. Patients with QTc prolongation on 12-lead ECG

10. Patients with a cardiac device (such as a pacemaker)

11. Patients that the researchers do not think fit into the group, including patients failed in compliance assessment